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- Lead local translational medicine team to collaborate with global RDPT on China development strategy for all assets involving China.
- Serves as local expert in DMPK, PKPD study, popPK and ethnicity sensitivity analysis to ensure data generated from global program and/or local studies meet and support the NDA/BLA filing in China.
- Work with corresponding global function to facilitate the development or transfer bioassays for key tissue biomarkers or patient selection biomarkers at local labs or external partners to enable the implementation of global program in China.
- Provide scientific input and contribute to the creation of relevant clinical deliverables, such as clinical trial protocols, Clinical Study Reports (CSRs) and submission dossiers/HA response document, ensuring high quality, accuracy and consistency with overall program goals and CDP.
- Communicate with CDE as needed, representing the interests of Biogen and patients, escalating matters in a timely manner to the appropriate internal stakeholders/external partners.
- Build up local functional team by strong people management and talent development, work with China affiliate leadership team to enhance Biogen’s influence in industry.
- PhD degree in clinical pharmacology or biology
- Fluent in English and Chinese (both verbal and written)
- A minimum of 10 years of relevant experience in clinical pharmacology or laboratory research
- Extensive experience of designing, running, and managing multiple research and early development programs, particularly in development within the neuroscience disease, is desirable
- Excellent communication and influence skills, open-minded, and adaptive
- Ability to represent China’s perspective on project teams, committees, and external meetings
- Ability to work effectively in a cross-functional setting and use a team approach to decision making
- Proven ability to work collaboratively with colleagues to guide clinical development plan
- Flexible and able to work in a fast-paced, rapidly change and multi-culture environment
The role will lead and support China clinical development strategy and implementation for all programs involving China from perspectives of preclinical, biomarker and clinical pharmacology. Activities include interfacing with the Global product teams to prioritize the Biogen portfolio from a China perspective and ensure China join the global program with assets at early stage. The responsibilities include but is not limited to supporting PK/PD study, popPK, ethnicity sensitivity, development of bioassay/gene testing or transfer to local lab, and interpretation of preclinical data to justify the early stage clinical trial in Chinese population, by collaboration with RDPT. This leadership role will interact with both cross-functional teams within Biogen and with external stakeholders or partners (e.g. due diligence), and be responsible for building up a strong functional team in China R&D.
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